Malaria, Falciparum Clinical Trial
Official title:
A Comparative Assessment of the Effectiveness of Artemether Plus Lumefantrine Versus Artesunate Plus Amodiaquine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria
The purpose of this study is to compare the effectiveness and safety of two Artemisinin Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium falciparum malaria
Status | Terminated |
Enrollment | 245 |
Est. completion date | October 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
Inclusion Criteria: - Male and female outpatients aged 6 months to 59 months - Absence of severe malnutrition - A slide-confirmed P. falciparum asexual parasitaemia between 2,000/µl and 200,000/µl - A measured axillary temperature = 37.5 °C or rectal/tympanic temperature = 38.0 °C - Absence of general danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit) - Ability to tolerate oral therapy - Permanent residence in study area - Informed consent by the legal representative of the subject, if possible, the parents Exclusion Criteria: - Adequate anti-malarial treatment within the previous 7 days - Antibiotic treatment for a current infection - Previous participation in a clinical trial - Haemoglobin < 5 g/dl - Leucocyte count: > 15000/µl - Mixed plasmodial infection - Severe malaria as defined by WHO recommendations - Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection) or concomitant disease masking assessment of response - History of allergy or intolerance against trial medication |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ghana | Agogo Presbyterian Hospital | Agogo | Asante Akim North District |
Lead Sponsor | Collaborator |
---|---|
Bernhard Nocht Institute for Tropical Medicine | Kumasi Centre for Collaborative Research (KCCR), Presbyterian Health Service (PHS), School of Medical Sciences Kumasi (SMS/KNUST) |
Ghana,
Bukirwa H, Yeka A, Kamya MR, Talisuna A, Banek K, Bakyaita N, Rwakimari JB, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, Staedke SG. Artemisinin combination therapies for treatment of uncomplicated malaria in Uganda. PLoS Clin Trials. 2006 May;1(1):e7. Epub 2006 May 19. — View Citation
Makanga M, Premji Z, Falade C, Karbwang J, Mueller EA, Andriano K, Hunt P, De Palacios PI. Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data. Am J Trop Med Hyg. 2006 Jun;74(6):991-8. — View Citation
Mårtensson A, Strömberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, Olliaro P, Ali AS, Björkman A. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005 Oct 15;41(8):1079-86. Epub 2005 Sep 13. — View Citation
Mutabingwa TK, Anthony D, Heller A, Hallett R, Ahmed J, Drakeley C, Greenwood BM, Whitty CJ. Amodiaquine alone, amodiaquine+sulfadoxine-pyrimethamine, amodiaquine+artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial. Lancet. 2005 Apr 23-29;365(9469):1474-80. — View Citation
Price RN, Uhlemann AC, van Vugt M, Brockman A, Hutagalung R, Nair S, Nash D, Singhasivanon P, Anderson TJ, Krishna S, White NJ, Nosten F. Molecular and pharmacological determinants of the therapeutic response to artemether-lumefantrine in multidrug-resistant Plasmodium falciparum malaria. Clin Infect Dis. 2006 Jun 1;42(11):1570-7. Epub 2006 Apr 26. — View Citation
Sidhu AB, Uhlemann AC, Valderramos SG, Valderramos JC, Krishna S, Fidock DA. Decreasing pfmdr1 copy number in plasmodium falciparum malaria heightens susceptibility to mefloquine, lumefantrine, halofantrine, quinine, and artemisinin. J Infect Dis. 2006 Aug 15;194(4):528-35. Epub 2006 Jul 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical and PCR-controlled parasitological cure rate at day 28 | 28 days | ||
Secondary | Clinical and PCR-controlled parasitological cure rate at day 14 | 14 days | ||
Secondary | Effect on anaemia | 28 days | ||
Secondary | Molecular Drug Resistance Markers | 28 days | ||
Secondary | Recrudescence and Reinfection | 28 days | ||
Secondary | Effects on Gametocytemia | 28 days | ||
Secondary | Acceptance of Therapies | 7 days | ||
Secondary | Incidences of malaria episodes over a follow-up period of 1 year | 12 months |
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